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Compliance Investigator

Job Post Index 229E5A-Sy##
Location East Hanover, NJ
Description: Description
  • Author and oversee deviations, investigations, CAPAs, and related reports to closure within established timelines for the manufacturing department. Support technical operations with Controlled Changes.
  • Deviation and Investigation Management
  • Initiate deviations within required timeframes and document immediate actions
  • Perform impact assessments
  • Use process knowledge and root cause investigation tools to identify root causes of product and process deviations.
  • Support documentation of experimental plan, execution, and results to support investigations
  • Ensure robustness (complete, accurate and defendable) of all critical and major investigations
  • Author and execute any experiments or runs to support investigations.
  • Work cross-functionally to assess and analyze deviations and investigations to determine impact
  • Work cross-functionally to ensure production continues in a compliant manner in the event of a deviation and document accordingly.
  • Author investigations and support resolution of product complaints, Out Of Expectation, Out Of Specification, Out of Tolerance results
  • Develop and document effective corrective and preventative actions
  • Ensure all CAPAs are implemented through GMP systems (e.g. MBR revision, training, CR, etc.) in a timely manner
  • Monitor and ensure effectiveness checks of CAPAs are conducted
  • Communicate to the production team any training or awareness events to reinforce quality behaviors.
  • Develop and initiate Change Requests (CRs)
  • Manage all phases of a controlled change
  • Ensure that changes are implemented in a timely and compliant manner
  • Work with the Engineering/Facility/Metrology and Raw Materials/Supplier Quality/Procurement/Sourcing groups to resolve manufacturing vendor material, manufacturing environment, and equipment related issues.
  • Escalate deviations according to escalation guidelines.
  • Provide deviations details (root cause and CAPAs) until the escalation is resolved to the global escalation team.
  • Quality Events: Owns and manages Quality Events related to GMP manufacturing and or Warehousing
  • Communicates, escalates, initiates, and owns trend events under the QE module.
  • Ensure that the required CAPAs are communicated and created in order to eliminate or reduce reoccurrences
  • Support the site and global C&GT during self-inspection, audit/inspection readiness and support the backroom if required.
  • Opening of deviations within required timeframe; Closing of investigations within required timeframe; Effective CAPAs Success rate of internal audits and Health Authorities' inspections.
Skills: Qualifications
  • BSc. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree preferred.
  • Proven writing skills with technical documents
  • Fluent in speaking / writing in English
  • Minimum 5 years’ experience in GMP manufacturing role on the shop floor and/or QA/QC, preferred.
  • Skills in the following:
    • Operations
    • Aseptic Production
    • Writing Skills
    • QE
    • Audit
    • Audits
    • Closing
    • Documentation
    • Inspections
    • Internal Audits
    • Metrology
    • Process Improvements
    • Procurement
    • Supplier Quality
    • Training

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